Avita Medical Initiates Legal Proceedings to Cancel Renovacare Patent

May 10, 2017 09:05 PM Eastern Daylight Time

VALENCIA, Calif. & PERTH, Australia & CAMBRIDGE, England--(BUSINESS WIRE)--Avita Medical Limited (ASX:AVH;
OTCQX:AVMXY),
a regenerative medicine company focused on the treatment of wounds and
skin defects, has filed an Inter Partes Review (IPR) petition
against US Patent No. 9,610,430 (the ‘430 patent) owned by Renovacare
Sciences Corp., as Avita holds that all claims in the ‘430 patent are
unpatentable and should be cancelled.

Avita filed the IPR challenge with the US Patent Trial and Appeal Board
(PTAB), which has accepted the petition and will now decide whether the
case should come to trial. The IPR process allows a petitioner to
challenge the validity of a patent by looking at prior art consisting of
patents and printed publications. Avita’s IPR petition has been assigned
the Review Number IPR2017‐01243.

“We believe we have presented a very strong rationale to the PTAB as to
why this patent should never have been issued, and thus, we respectfully
request that all claims in the ‘430 patent should be cancelled,” said
Avita CEO Adam Kelliher. “Avita is a pioneer in the regenerative
medicine arena, and we are very protective of our intellectual property
rights.”

ABOUT AVITA MEDICAL LIMITED

Avita’s patented and proprietary collection and application technology
provides innovative treatment solutions derived from the regenerative
properties of a patient’s own skin. Our medical devices work
by preparing a Regenerative Epithelial Suspension (RES™), an autologous
suspension comprised of the patients’ own skin cells and wound healing
factors that are necessary to regenerate natural healthy skin. This is
then applied to the area to be treated.

In all countries outside of Europe, our portfolio is marketed under the
ReCell® brand to promote skin healing in a wide range of applications
including burns, chronic wounds and aesthetics.

ReCell® is TGA‐registered in Australia, and CFDA‐cleared in China. In
the United States, ReCell® is an investigational device limited by
federal law to investigational and compassionate use.

In Europe, our portfolio of medical device products received CE-mark
approval as three tailored product presentations, with three individual
brand names. ReCell® is designed for the treatment of burns and plastic
reconstructive procedures; ReGenerCell™ has been formulated for chronic
wounds including leg and foot ulcers; and ReNovaCell™ is tailored for
aesthetic applications including the restoration of pigmentation.

This letter includes forward-looking statements. These
forward-looking statements generally can be identified by the use of
words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,”
“believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,”
“project,” “continue,” “outlook,” “guidance,” “future,” other words of
similar meaning and the use of future dates. Forward-looking statements
in this letter include, but are not limited to, statements concerning,
among other things, our ongoing clinical trials and product development
activities, regulatory approval of our products, the potential for
future growth in our business, and our ability to achieve our key
strategic, operational and financial goal. Forward-looking statements by
their nature address matters that are, to different degrees, uncertain.
Each forward-looking statement contained in this letter is subject to
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statement. Applicable
risks and uncertainties include, among others, the timing of regulatory
approvals of our products; physician acceptance, endorsement, and use of
our products; failure to achieve the anticipated benefits from approval
of our products; the effect of regulatory actions; product liability
claims; risks associated with international operations and expansion;
and other business effects, including the effects of industry, economic
or political conditions outside of the company’s control. Investors
should not place considerable reliance on the forward-looking statements
contained in this letter. Investors are encouraged to read our publicly
available filings for a discussion of these and other risks and
uncertainties. The forward-looking statements in this letter speak only
as of the date of this release, and we undertake no obligation to update
or revise any of these statements.